By the end of September 2017, the company plans to launch Exalgo 32mg extended release tablets (hydromorphone HCl) in the US market.
The company said Exalgo 32mg extended release tablets (hydromorphone HCl) is an opioid agonist indicated for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.
Biopharmaceutical company Zalicus Inc (NasdaqGM:ZLCS) said on Monday that the US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for the 32 mg dose strength of EXALGO
(hydromorphone HCl) Extended-Release Tablets (CII).
CombinatoRx has the potential to create a thriving biopharmaceutical business based on the nearer-term revenue-generating potential of our partnered product assets, such as Exalgo
and Prednisporin, while focusing internal efforts on key programs in our product pipeline with the highest likelihood of creating value going forward.
The indication for Exalgo
(available in 8-, 12-and 16-mg tablets) is once-daily administration for the management of moderate to severe pain in opioid-tolerant patients requiring round-the-clock opioid analgesia for an extended period.
At the meeting, efficacy and safety data and details of the Risk Evaluation and Mitigation Strategies (REMS) for Exalgo
were presented by officials from Neuromed Pharmaceuticals and Covidien, which has acquired the U.S.
Covidien said Exalgo
recently met its goal in a late stage clinical trial, and the Food and Drug Administration is scheduled to rule on the drug's approval by Nov.
Under terms of the deal, Mallinckrodt has agreed to grant Watson a licence to US patents relating to Exalgo
without the payment of any royalties.
If approved, it will be marketed by Covidien as Exalgo
and will be the only extended-release formulation of the drug.
Watson's Hydromorphone Hydrochloride Extended-release Tablets are a generic version of Mallinckrodt Inc's Exalgo
tablets, which are indicated for once daily administration for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.
26 April 2010 - Ireland-based and US-listed healthcare company Covidien Plc (NYSE: COV) introducedaA today EXALGO
(hydromorphone HCI) Extended-Release Tablets, (CII), the only extended-release hydromorphone treatment available in the USA.
Covidien has updated its sales guidanceaA for the entire fiscal 2009/10aA aA to reflect the recent strengthening of the US dollar against most currencies, the approval of EXALGO
, the sale of the US nuclear pharmacies, coupled with weakness in certain product lines.